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The variables LBORNRLO, LBORNRHI, LBSTNRLO, LBSTNRHI, LBNRIND and LBLOBXFL are expected variables. but are typically not used in these types of studies. Hence these variables are included in the datset dataset but the values may be are null. These variables are not included below to save space.
For lab tests where the specimen is collected over time (e.g., 24-hour urine collection), the start date/time of the collection is represented in LBDTC and the end date/time of collection is represented in LBENDTC. LBDTC and LBENDTC dates are based on the specimen collection date. If the date of the assay is needed, it can be added as a non-standard variable.
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The biomarkers were categorized using LBCAT and LBSCAT. These categories were based on the scientific classification of the type of biomarker and the associated constituent being evaluated by the biomarker test. Other categorization may be done by the sponssor, based on the study design. These may include using Biomarker of Tobacco Exposure, Biomarkers of Harm or Potential Harm, Biomarkers of Compliance, etc. The LBSCAT can be used to provide the type of markers (e.g., Tobacco Alkaloid, Polynuclear Aromatic Hydrocarbons, Tobacco Specific Nitrosammines) or the health impact of the biomarker (e.g., cancer, cardiovascular disease, respiratory effects, reproductive problems, and or addiction).
Total Nicotine equivalents (TNE-7) were calculated by the sponsor based on the data below and represented in an ADaM dataset. Total Nicotine equivalents are the sum of nicotine, cotinine, 3-hydroxycotinine and their glucuronide conjugates. Other estimates of TNE can be used and are typically denoted using terms like TE-2, TE-3. For example TE-2 is the sum of cotinine + 3'-hydroxycotinine.
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| Rows 1-2: | Show the nicotine and cotinine measurements from a serum blood sample. These tests were performed at every visit but only the nicotine results at Visit 1, and the cotinine results at Visit 3 are shown. | | Rows 3-4: | Urine creatinine and 24-hour urine volume is are shown. | | Rows 5-16: | Show various biomarkers related to Tobacco Alkaloids. These were obtain obtained from a planned 24-hour urine sample. The start and end time of the urine collection are provided in LBDTC and LBENDTC. Only the results from Day 180 are shown. |
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| Row | STUDYID | DOMAIN | USUBJID | LBSEQ | LBTESTCD | LBTEST | LBCAT | LBSCAT | LBORRES | LBORRESU | LBSTRESC | LBSTRESN | LBSTRESU | LBNAM | LBLOINC | LBSPEC | LBMETHOD | LBLOBXFL | LBLLOQ | VISITNUM | VISIT | LBDTC | LBENDTC |
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| 1 | TOB777 | LB | 001 | 1 | NICOTINE | Nicotine | TOBACCO ALKALOID | NICOTINE | 30 | ng/mL | 30 | 30 | ng/mL | Tobacco Marker Testing Laboratory | 3853-9 | SERUM | LC/MS/MS | Y | 2 | 1 | BASELINE | 2021-01-17 |
| | 2 | TOB777 | LB | 001 | 2 | COTININE | Cotinine | TOBACCO ALKALOID | NICOTINE | 400 | ng/mL | 400 | 400 | ng/mL | Tobacco Marker Testing Laboratory | 10365-5 | SERUM | LC/MS/MS |
| 2 | 3 | Day 180 | 2021-07-20 |
| | 3 | TOB777 | LB | 002 | 1 | CREAT | Creatinine | 24-HOUR URINE TEST |
| 0.8 | ng/mL | 0.8 | 0.8 | ng/mL | Tobacco Marker Testing Laboratory | 65634-8 | URINE | LC-MS-MS | Y |
| 1 | BASELINE | 2021-06-21T08:00 | 2021-06-22T08:00 | | 4 | TOB777 | LB | 002 | 2 | VOLUME | Volume | 24-HOUR URINE TEST |
| 1875 | mL | 1875 | 1875 | mL | Tobacco Marker Testing Laboratory |
| URINE |
| Y |
| 1 | BASELINE | 2021-06-21T08:00 | 2021-06-22T08:00 | | 5 | TOB777 | LB | 002 | 3 | NICOTINE | Nicotine | TOBACCO ALKALOID | NICOTINE | 45 | ng/mL | 45 | 45 | ng/mL | Tobacco Marker Testing Laboratory | 3854-7 | URINE | LC-MS/MS |
| 0.2 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 6 | TOB777 | LB | 002 | 4 | NICGLUC | Nicotine-glucuronide | TOBACCO ALKALOID | NICOTINE | 40 | ng/mL | 40 | 40 | ng/mL | Tobacco Marker Testing Laboratory |
| URINE |
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| 0.2 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 7 | TOB777 | LB | 002 | 5 | NOXT | Nicotine-1 N-oxid | TOBACCO ALKALOID | NICOTINE | 113.5 | ng/mL | 113.5 | 113.5 | ng/mL | Tobacco Marker Testing Laboratory |
| URINE | HPLC-ESI-MS/MS |
| 2.50 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 8 | TOB777 | LB | 002 | 6 | COTININE | Cotinine | TOBACCO ALKALOID | NICOTINE | 300 | ng/mL | 300 | 300 | ng/mL | Tobacco Marker Testing Laboratory | 10366-3 | URINE | LC/MS/MS) |
| 0.05 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 9 | TOB777 | LB | 002 | 7 | COTGLUC | Cotinine-glucuronide | TOBACCO ALKALOID | NICOTINE | 275 | ng/mL | 275 | 275 | ng/mL | Tobacco Marker Testing Laboratory |
| URINE |
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| 0.2 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 10 | TOB777 | LB | 002 | 8 | COXT | Cotinine-n-oxide | TOBACCO ALKALOID | NICOTINE | 117.5 | ng/mL | 117.5 | 117.5 | ng/mL | Tobacco Marker Testing Laboratory |
| URINE | HPLC-ESI-MS/MS |
| 2.02 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 11 | TOB777 | LB | 002 | 9 | OHCOT or HCTT | Trans-3-hydroxycotinine | TOBACCO ALKALOID | NICOTINE | 2000 | ng/mL | 2000 | 2000 | ng/mL | Tobacco Marker Testing Laboratory | 33916-8 | URINE |
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| 0.1 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 12 | TOB777 | LB | 002 | 10 | OHCOTG or 3HC-Gluc | Trans-3-hydroxycotinine glucuronide | TOBACCO ALKALOID | NICOTINE | 3529 | ng/mL | 3529 | 3529 | ng/mL | Tobacco Marker Testing Laboratory |
| URINE |
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| 0.03 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 13 | TOB777 | LB | 002 | 11 | NORNCTN or NNIC | Nornicotine | TOBACCO ALKALOID | NICOTINE | 6 | ng/mL | 6 | 6 | ng/mL | Tobacco Marker Testing Laboratory | 33917-6 | URINE | LC/MS/MS |
| 2.50 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 14 | TOB777 | LB | 002 | 12 | ANBS | Anabasine | TOBACCO ALKALOID | NICOTINE | 5 | ng/mL | 5 | 5 | ng/mL | Tobacco Marker Testing Laboratory | 33915-0 | URINE | LC/MS/MS |
| 0.51 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 15 | TOB777 | LB | 002 | 13 | NCOT | Norcotinine | TOBACCO ALKALOID | NICOTINE | 2 | ng/mL | 2 | 2 | ng/mL | Tobacco Marker Testing Laboratory | 77740-9 | URINE |
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| 1.11 | 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 16 | TOB777 | LB | 002 | 14 | ANTB | Anatabine | TOBACCO ALKALOID | NICOTINE | 9.1 | ng/mL | 9.1 | 9.1 | ng/mL | Tobacco Marker Testing Laboratory |
| URINE | HPLC-ESI-MS/MS |
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| 3 | Day 180 | 2021-12-15T08:00 | 2021-12-16T08:00 | | 17 | TOB777 | LB | 2001 | 1 | OH_2_FLU or 2-FLU | 2-Hydroxyfluorene 3‐Hydroxyfluorene (3‐FLU) | POLYNUCLEAR AROMATIC HYDROCARBON |
| 30 | ng/mL | 30 | 30 | ng/mL | Tobacco Marker Testing Laboratory | 3853-9 | URINE | LC-MS/MS | 3853-9 |
| 2 | Day 60 | 2021-09-15T010:00 | 2021-09-16T009:20 | | 18 | TOB777 | LB | 2001 | 2 | OH1NAPHT | 1-Hydroxynaphthalene | POLYNUCLEAR AROMATIC HYDROCARBON |
| 400 | ng/mL | 400 | 400 | ng/mL | Tobacco Marker Testing Laboratory | 10365-5 | URINE | LC-MS/MS | 10365-5 |
| 2 | Day 60 | 2021-09-15T010:00 | 2021-09-16T009:20 | | 19 | TOB777 | LB | 2001 | 3 | OH1PHE | 1-Hydroxyphenanthrene | POLYNUCLEAR AROMATIC HYDROCARBON |
| 45 | ng/mL | 45 | 45 | ng/mL | Tobacco Marker Testing Laboratory | 3854-7 | URINE | LC-MS/MS | 3854-7 |
| 2 | Day 60 | 2021-09-15T010:00 | 2021-09-16T009:20 | | 21 | TOB777 | LB | 2001 | 4 | OH3BAP | 3-Hydroxybenzo[a]pyrene | POLYNUCLEAR AROMATIC HYDROCARBON |
| 300 | ng/mL | 300 | 300 | ng/mL | Tobacco Marker Testing Laboratory | 10366-3 | URINE | LC-MS/MS | 10366-3 |
| 2 | Day 60 | 2021-09-15T010:00 | 2021-09-16T009:20 | | 22 | TOB777 | LB | 2001 | 5 | CO | Carbon Monoxide | VARIOUS GASES |
| 10 | % | 10 | 10 | % | Tobacco Marker Testing Laboratory |
| EXPIRED AIR | Multiple Wavelength Spectrophotometer |
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| 2 | Day 60 | 2021-09-15 |
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The 2 rows of supplb.xpt add qualifying information to the laboratory data collected (RDOMAIN = "LB"). IDVAR defines the key variable used to link this information to the LB data (LBSEQ). IDVARVAL specifies the value of the key variable within the parent LB record to which the SUPPLB record applies. The remaining columns specify the supplemental variables’ variable names (LBNVOID and LBNMVIOD, labels, values, origin.
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